Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Yafho Bio - Technology CO. Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 023 12 16 000
  • Event Initiated Date
    2016-12-06
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10347
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    In the course of our post market surveillance activities we observed that the ultrasound probe cover kit with gel was found the burkholderia multivorans, bukholderia cenocepacia, bacillus beringensis, bacillus circulans inside, which pointed that the gel was the source of pollution.

Device

ULTRASOUND PROBE COVER KIT WITH GEL
  • Model / Serial
    ITEM NUMBER: 654005 ITEM NAME: ULTRASOUND PROBE COVER KIT WITH GEL BATCH NUMBER: 20150701 / 20160201
  • Product Description
    single use device
  • Manufacturer
    Yafho Bio - Technology CO. Ltd

Manufacturer

Yafho Bio - Technology CO. Ltd